October 20, 2020

The Niche

Knoepfler lab stem cell blog

bioethics

3 min read

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with …Read More

4 min read

The FDA sent a stern letter today to Dr. John Zhang, PhD, MD, the physician who last year created a genetically modified human embryo in the U.S. and then exported it to Mexico where he self-reported creating a genetically modified baby boy. While the genetically modified baby created in Mexico was reportedly seemingly OK, it’s not clear what kind of health issues he might face in the future and I haven’t seen much data on him. I believe his parents subsequently declined to have him participate …Read More

2 min read

The human embryo CRISPR paper with Shoukhrat Mitalipov as senior author is coming soon. It will reportedly be focused on the use of CRISPR to genetically modify viable human embryos for reversal of a disease-associated mutation. While strangely press already broke early on this paper last week, as much as a week before the paper comes out, and that press suggests very positive data, how clear will that be from the paper itself? Here are some ideas on the big 5 questions (some include …Read More

11 min read

Below is a conversation with bioethics commentator Kelly Hills (who BTW has a great blog), tackling some of the key issues surrounding the potential use of CRISPR-Cas9 technology to make heritable human genetic modification. I really appreciate her clear and insightful answers to some tough questions that many are grappling with today on this topic. Part of the possible power of some forms of human genetic modification procedures being considered for potential future use is that they are heritable. This means, for example, that embryonic …Read More